A Study to Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function
NCT01419041
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
All Subjects
- Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 65 years, inclusive ('healthy' is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG, and clinical laboratory tests).
- Body Mass Index (BMI) of 18 to 40 kg/m2 inclusive; and a total body weight >50 kg (>110 lbs).
Subjects with Normal Renal Function (Group 1)
- Normal renal function (CLcr =>90 mL/min) during the screening period.
- Matched 1-to-1 to subjects in Group 2 with respect to age (+/-5 years), weight (+/-10 kg), gender, and race according to protocol.
Subjects with Severe Renal Impairment (Groups 2)
- Good general health commensurate with the population with chronic kidney disease.
- Severe renal impairment (CLcr<30 mL/min) during the screening period.
All Subjects
- Renal allograft recipients.
- Any condition possibly affecting drug absorption.
- 12 lead ECG demonstrating QTc >470 msec at screening.
- Urinary incontinence without catheterization.
- A positive urine drug screen.
- History of regular alcohol consumption.
- Treatment with an investigational drug within 30 days (or as determined by the local
requirement, whichever is longer) or 5 half lives preceding the first dose of study
medication.
- Pregnant or nursing females; females of childbearing potential, including those with
tubal ligation.
- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
Subjects with Severe Renal Impairment (Groups 2)
- Subjects with any significant hepatic, cardiac or pulmonary disease (apart from stable
ischemic heart disease), or subjects who are clinically nephrotic.
- Subjects requiring hemodialysis.
- Subjects with strict fluid restriction (ie, <1500 mL/24 hours).
- Significant bleeding diathesis which could preclude multiple venipuncture.
- Use of food or drugs that are CYP3A4 inhibitors and inducers.
- Herbal supplements and hormone replacement therapy must be discontinued 28 days prior
to the first dose of trial medication
- Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
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Descriptive Information | ||||
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Brief Title ICMJE | A Study to Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function | |||
Official Title ICMJE | A Phase I, Single Dose, Parallel-Group Study To Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function | |||
Brief Summary | The present study is being conducted to evaluate whether or not severe renal impairment has an effect on crizotinib Pharmacokinetics. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science | |||
Condition ICMJE | Renal Impairment | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 16 | |||
Original Estimated Enrollment ICMJE | 24 | |||
Actual Study Completion Date ICMJE | August 2012 | |||
Actual Primary Completion Date | August 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: All Subjects
Subjects with Normal Renal Function (Group 1)
Subjects with Severe Renal Impairment (Groups 2)
Exclusion Criteria: All Subjects
Subjects with Severe Renal Impairment (Groups 2)
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01419041 | |||
Other Study ID Numbers ICMJE | A8081020 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | September 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |